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J Nucl Med. 2008; 49 (Supplement 1):70P
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Cardiovascular: Clinical Science

New Software, Hardware and Tracer Development I

First human study of BMS747158, a novel F-18 labeled tracer for myocardial perfusion imaging

Jamshid Maddahi1, Christiaan Schiepers1, Johannes Czernin1, Henry Huang1, Heinrich Schelbert1, Anna Wijatyk2, Mark Hibberd2, Joel Lazewatsky2, Richard Sparks2 and Michael Phelps1

1 Molecular and Medical Pharmacology (Nuclear Medicine), David Geffen School of Medicine at UCLA, Los Angeles, California; 2 Bristol-Myers Squibb Medical Imaging, Billerica, Massachusetts

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Objectives: Human safety, biodistribution, dosimetry, and myocardial imaging characteristics of F-18 labeled BMS747158 that targets mitochondrial complex 1, was evaluated in Phase I clinical trial.

Methods: To date 4 of planned 15 normal subjects were injected with 150-260 MBq of BMS747158 intravenously. Dynamic PET was obtained over the heart for 10 minutes (min), followed by sequential whole body imaging for 5 hours. Blood samples were obtained and heart rate, ECG and blood pressure were monitored prior to and during imaging. The Residence times were determined from multi-exponential regression of organ ROI data normalized by injected dose. Radiation dose estimates were calculated using the MIRD schema with OLINDA/EXM. Myocardial (M), lung, liver and blood pool (B) SUV’s were determined at different intervals.

Results: No adverse events were noted. The top four highest-dose organs and their respective mean dose estimates were kidneys (0.065+0.014 mSv/MBq), urinary bladder (2-hr void, 0.055+0.016 mSv/MBq), myocardium (0.049+0.005 mSv/MBq) and liver (0.044+0.008 mSv/MBq). Mean effective dose was 0.02+0.002 mSv/MBq. Excellent M/background was noted due to high M SUV,that remained constant for the duration of imaging, and clearance from background organs.


Figure 1

Conclusions: These preliminary data suggest that F-18 labeled BMS747158 is safe and has a unique potential for myocardial perfusion PET imaging.





This Article
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Right arrow Articles by Phelps, M.